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PharmaCompass offers a list of Carglumic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Carglumic Acid manufacturer or Carglumic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carglumic Acid manufacturer or Carglumic Acid supplier.
PharmaCompass also assists you with knowing the Carglumic Acid API Price utilized in the formulation of products. Carglumic Acid API Price is not always fixed or binding as the Carglumic Acid Price is obtained through a variety of data sources. The Carglumic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Carglumic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carglumic Acid, including repackagers and relabelers. The FDA regulates Carglumic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carglumic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Carglumic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carglumic Acid supplier is an individual or a company that provides Carglumic Acid active pharmaceutical ingredient (API) or Carglumic Acid finished formulations upon request. The Carglumic Acid suppliers may include Carglumic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Carglumic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carglumic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Carglumic Acid active pharmaceutical ingredient (API) in detail. Different forms of Carglumic Acid DMFs exist exist since differing nations have different regulations, such as Carglumic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carglumic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Carglumic Acid USDMF includes data on Carglumic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carglumic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carglumic Acid suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Carglumic Acid Drug Master File in Japan (Carglumic Acid JDMF) empowers Carglumic Acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Carglumic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Carglumic Acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Carglumic Acid suppliers with JDMF on PharmaCompass.
A Carglumic Acid written confirmation (Carglumic Acid WC) is an official document issued by a regulatory agency to a Carglumic Acid manufacturer, verifying that the manufacturing facility of a Carglumic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Carglumic Acid APIs or Carglumic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Carglumic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Carglumic Acid suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Carglumic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Carglumic Acid API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Carglumic Acid as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Carglumic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Carglumic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Carglumic Acid suppliers with NDC on PharmaCompass.
Carglumic Acid Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Carglumic Acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Carglumic Acid GMP manufacturer or Carglumic Acid GMP API supplier for your needs.
A Carglumic Acid CoA (Certificate of Analysis) is a formal document that attests to Carglumic Acid's compliance with Carglumic Acid specifications and serves as a tool for batch-level quality control.
Carglumic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Carglumic Acid CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Carglumic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Carglumic Acid EP), Carglumic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carglumic Acid USP).